FORTIFY ASSURA DR ICD, US CD2357-40Q

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for FORTIFY ASSURA DR ICD, US CD2357-40Q manufactured by St. Jude Medical, Inc.(crm-sylmar).

Event Text Entries

[185942646]
The results/method and conclusion codes along with investigation results will be provided in the final report. Patient Sequence No: 1, Text Type: N, H10

[185942647]
Following the battery performance alert (bpa) advisory, a bpa was received by the clinician and the device was explanted. The patient was in stable condition throughout. Patient Sequence No: 1, Text Type: D, B5